CSV Validation Engineer

Computer Systems Validation Specialist

Define validation strategy for computerized systems and platforms utilized in GxP space.

• Create validation deliverables such as validation plan, test protocols, traceability matrix and execution of protocols
• Participate in user review meetings, discussions with quality assurance and compliance groups
• Participate/conduct risk assessments
• Develop and maintain policies and procedures
• Effectively communicate the validation activities and deliverables to the project team, customer stakeholders and global team within Zifo
• Act as a liaison between Zifo remote teams and customers in US & Canada
• Participate in internal initiatives around computer systems validation

Qualifications

• Bachelor or master's degree in life sciences or computer sciences
• 7-10 years' experience with computer systems validation is required for this role
• Strong knowledge of GxP requirements, GCP regulations, 21 CFR part 11 requirements
• Must have experience with validation of IT infrastructure systems including R, SAS etc
• Experience with GxP systems validation like ELN, LIMS, QMS etc
• Experience with Veeva vault systems
• Clinical experience is must.